Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified August 2025 by VistaGen Therapeutics, Inc.
Sponsor
VistaGen Therapeutics, Inc.
Information Provided by (Responsible Party)
VistaGen Therapeutics, Inc.
Clinicaltrials.gov Identifier
NCT06615557
Other Study ID Numbers:
PH94B-CL043
First Submitted
September 23, 2024
First Posted
September 25, 2024
Last Update Posted
February 4, 2026
Last Verified
August 2025

ClinicalTrials.gov processed this data on February 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Social Anxiety Disorder (SAD)
Drug: Fasedienol Nasal SprayDrug: Placebo Nasal Spray

Study Design

Study TypeInterventional
Actual Enrollment236 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleUS, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Fasedienol Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects With Social Anxiety Disorder, With an Open-Label Extension (PALISADE-4)
Study Start DateSeptember 15, 2024
Actual Primary Completion DateMarch 31, 2026
Actual Study Completion Date11mos 2w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Fasedienol Nasal Spray
Drug: Fasedienol Nasal Spray
Nasal spray delivered 20 minutes before the PSC
Placebo Nasal Spray
Drug: Placebo Nasal Spray
Nasal spray delivered 20 minutes before the PSC

Outcome Measures

Primary Outcome Measures
  1. Subjective Units of Distress Scale (SUDS)
    The SUDS is a patient self-rated scale that is scored in the range of 0 to 100 (operationalized for participants in this study as 0=totally relaxed or no anxiety and 100=highest distress or anxiety ever felt).
Secondary Outcome Measures
  1. Global Impression Scale of Improvement (CGI-I)
    The CGI-I scale is a clinician-rated scale to assess illness improvement. The CGI-I scale includes one item being scored from 1 (best outcome) to 7 (worst outcome) with 4 being no change.
  2. Patient Global Impression of Change (PGI-C)
    The PGI-C is a patient self-rated scale to assess improvement. The PGI-C includes 7 items being scored from 1 (best outcome) to 7 (worst outcome) with 4 being no change.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Written informed consent provided prior to conducting any study-specific assessment.
Male and female adults, 18 through 65 years of age, inclusive.
Current diagnosis of SAD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, and confirmed by the Mini-International Neuropsychiatric Interview (MINI).
Clinician-rated Liebowitz Social Anxiety Score (LSAS) total score ≥70 at Screening (Visit 1).
Clinician-rated Hamilton Depression Rating Scale (HAM-D) (17-items) total score \<16.
Female subjects of childbearing potential must be able to commit to the consistent and correct use of an effective method of birth control throughout the study
Subjects must have normal olfactory function
Exclusion Criteria
Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, psychosis, anorexia or bulimia, premenstrual dysphoric disorder, autism spectrum disorder, or obsessive-compulsive disorder.
Any other current principal or personality disorder (previously known as Axis I or Axis II disorders), except for specific phobias or generalized anxiety disorder, provided that these are not the primary diagnosis.
Subjects who meet criteria for moderate or severe alcohol use disorder within the 1 year prior to study entry, or any use of illicit substances or tetrahydrocannabinol ("THC") within 2 months prior to study entry.
In the opinion of the investigator, the subject has a significant risk for suicidal behavior during the course of their participation in the study, or the subject is considered to be an imminent danger to themself or others.
Clinically significant nasal pathology or history of significant nasal trauma, nasal surgery, total anosmia, or nasal septum perforation that may have damaged the nasal chemosensory epithelium.
Two or more documented failed adequate treatment trials with a registered medication approved for SAD.
Currently receiving cognitive-behavioral therapy (CBT), exposure therapy, or acceptance and commitment therapy.
Subjects taking psychotropic medications within 30 days before Visit 2.
Use of any over-the-counter product, prescription product, off-label treatment, cannabidiol ("CBD"), or herbal preparation for treatment of the symptoms of anxiety or social anxiety within 30 days before Visit 2.
Prior participation in a clinical trial involving fasedienol.
Participation in any other clinical trial within the last 30 days or during the course of the current trial.
Subjects with a positive urine drug screen.
Women who have a positive urine pregnancy test.
Women who are currently breastfeeding are not eligible unless they are willing to stop breastfeeding for the duration of the study.
Subjects who have tested positive and/or have exhibited symptoms consistent with SARS-CoV-2 infection during the 4 weeks prior to Screening (Visit 1).
Any clinically significant medical history or findings as determined by the Investigator that could interfere with the objectives of the study or put the participant at risk.

Contacts and Locations

Sponsors and CollaboratorsVistaGen Therapeutics, Inc.
Locations
Vistagen Clinical Site | Phoenix Arizona, United States, 85012Vistagen Clinical Site | Little Rock Arkansas, United States, 72211Vistagen Clinical Site | Bellflower California, United States, 90706Vistagen Clinical Site | Oceanside California, United States, 92056Vistagen Clinical Site | Orange California, United States, 92868Vistagen Clinical Site | Redlands California, United States, 92374Vistagen Clinical Site | Torrance California, United States, 90504Vistagen Clinical Site | Denver Colorado, United States, 80209Vistagen Clinical Site | Tampa Florida, United States, 33629Vistagen Clinical Site | Decatur Georgia, United States, 30030Vistagen Clinical Site | Chicago Illinois, United States, 60640Vistagen Clinical Site | Naperville Illinois, United States, 60563Vistagen Clinical Site | Boston Massachusetts, United States, 02131Vistagen Clinical Site | Bloomfield Township Michigan, United States, 48302Vistagen Clinical Site | Flowood Mississippi, United States, 39232Vistagen Clinical Site | Las Vegas Nevada, United States, 89119Vistagen Clinical Site | Las Vegas Nevada, United States, 89121Vistagen Clinical Site | Albuquerque New Mexico, United States, 87109Vistagen Clinical Site | New York New York, United States, 10128Vistagen Clinical Site | Cincinnati Ohio, United States, 45229Vistagen Clinical Site | Austin Texas, United States, 78737Vistagen Clinical Site | Austin Texas, United States, 78759Vistagen Clinical Site | Dallas Texas, United States, 75251Vistagen Clinical Site | Houston Texas, United States, 77055Vistagen Clinical Site | San Antonio Texas, United States, 78229Vistagen Clinical Site | Everett Washington, United States, 98201